MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STERETACTIC DEVICE, ROBOTICS

Catalog Number 209999

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

The partial knee arthroplasty surgery was prolonged due to need for troubleshooting steps and trying to reestablish registration of rio robotic arm.The tibial resection was completed using competitor instruments.Advised "off label.

Manufacturer Narrative

Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999, serial #: (b)(4).Robot error was displayed and the arm brakes locked.Device history: a review of the device history records shows that all qips associated with the build of (b)(4) were signed off and all qts reconciled.Final qa signature for acceptance was added on june 24, 2016.Device inspection: the device was inspected and the results documented in gsp case # (b)(4) as shown below.Cpci removed pn 211123 lot 21112358-2.Successfully replaced cpci following rio service manual.All testing successfully performed following rio service manual.Complaint history: a review of the complaint database shows that a similar complaint was made for the referenced serial number.The complaint is (b)(6) pr# (b)(4).Conclusion: the failure mode of a rio robotic arm, catalog# 209999, s/n (b)(4) was confirmed.The issue occurred during a case and resulted in the case being completed by manual instrumentation.A replacement arm was sent to the customer and the malfunctioning arm was repaired.Further action: no further action at this time.

Event Description

The partial knee arthroplasty surgery was prolonged due to need for troubleshooting steps and trying to reestablish registration of rio robotic arm.The tibial resection was completed using competitor instruments.Advised off label.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STERETACTIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: liza gordillo ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6074339
• MDR Text Key: 59015485
• Report Number: 3005985723-2016-00359
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1